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1,162 stories matching this filter · ← front page

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  • AusperBio secures $120 million Series C to push hepatitis B antisense therapy into Phase 3
    AusperBio Therapeutics announced it has closed a $120 million Series C financing round aimed at moving its hepatitis B antisense oligonucleotide candidate toward late‑stage trials and eventual mark…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Roche pays $190 million for rights to Hanmi's UCN2 analog targeting obesity with muscle-preserving effects
    Roche's Genentech unit has agreed to pay $190 million upfront for rights to HM17321, a urocortin‑2 analog developed by South Korea’s Hanmi Pharmaceutical, covering markets outside South Korea. The…
    Fierce Biotech · 2mo agoDealPositive↗ source
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  • Genentech pays $45M upfront to DualityBio for ADC platform targeting resistant cancers
    Genentech has agreed to pay DualityBio $45 million upfront for rights to its antibody‑drug conjugate (ADC) technology, with the agreement offering more than $1 billion in potential milestone paymen…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • BioNTech-Genentech halts colorectal cancer vaccine trial after higher death rate in vaccine arm
    BioNTech and Genentech stopped a phase 2 trial of their personalized mRNA vaccine BNT122 in patients with stage 2 or 3 colorectal cancer after an independent data safety monitoring board found more…
    Fierce Biotech · 2mo agoNegative readoutNegative↗ source
  • FDA sends warning to Alar over misleading claims about investigational depression drug
    The U.S. Food and Drug Administration’s Office of Prescription Drug Promotion sent an untitled warning letter to Alar Pharmaceuticals. The agency says Alar’s promotional materials for ALA-3000, an…
    raps · 2mo agoRegulatoryNegative↗ source
  • FDA considers two new executive posts and approves first-of-its-kind early drug and ketone‑glucose wearable
    The Health and Human Services department is reportedly evaluating the creation of two additional senior positions within the FDA, a step that could increase agency oversight. In recent approvals,…
    raps · 2mo agoRegulatoryNeutral↗ source
  • Teva named stalking horse bidder to acquire BioXcel's neuroscience assets for $57.5 million
    BioXcel Therapeutics, a Connecticut biotech focused on neuroscience, filed for Chapter 11 bankruptcy after running out of cash to fund operations through August. In the filing, the company selecte…
    Fierce Biotech · 2mo agoDealNeutral↗ source
  • CEPI pledges up to $16.5M to advance Egyptian biotech's Ebola vaccine candidate
    CEPI has committed up to $16.5 million to help bring Minapharm’s Bundibugyo Ebola vaccine candidate into clinical testing. The funding will support preclinical work and an early-stage human trial…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • FDA greenlights first oral therapy for adult dermatomyositis
    The U.S. Food and Drug Administration has approved Lisraya (brepocitinib) tablets as a treatment for adults with dermatomyositis. Dermatomyositis is a rare autoimmune condition that attacks muscle…
    fda press · 2mo agoApprovalPositive↗ source
  • Roche receives expanded FDA clearance for HER2 diagnostic tests linked to Jazz’s Ziihera cancer drug
    Roche announced that the U.S. Food and Drug Administration has broadened the clearance for two of its HER2 diagnostic assays, allowing their use in metastatic gastroesophageal adenocarcinoma. The…
    Fierce Biotech · 2mo agoCRLPositive↗ source
  • FDA grants emergency use authorization for generic Bimectin injection to prevent screwworm in cattle
    The U.S. Food and Drug Administration announced an Emergency Use Authorization for the generic ivermectin product Bimectin injection, allowing its use to prevent New World screwworm infestations in…
    fda press · 2mo agoRegulatoryPositive↗ source
  • UK reduces drug rebate rate to 14.5% after a year of pharma pull-back, following US trade deal
    In September 2025, relations between the UK government and major pharmaceutical companies hit a low point when the government announced a steep increase in the share of sales of new branded medicin…
    Fierce Biotech · 2mo agoRegulatoryNeutral↗ source
  • Vivace Therapeutics appoints Craig Gibbs as CEO and Ellen Lubman as chief business officer ahead of phase 3 mesothelioma trial
    Vivace Therapeutics announced two senior leadership appointments. Craig Gibbs, Ph.D., will serve as the company’s president and chief executive officer, while Ellen Lubman joins as chief business a…
    Fierce Biotech · 2mo agoPositive↗ source
  • Osivax licenses GC Biopharma seasonal flu vaccine to develop combined OVX836-GC FLU shot
    Osivax has secured a non-exclusive license from GC Biopharma for its seasonal influenza vaccine, GC FLU, to pair with Osivax’s mid-phase candidate OVX836. OVX836 targets the conserved nucleoprotei…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • FDA review highlights expanding role of manufacturing process models in drug applications
    The FDA released a review outlining how manufacturers can incorporate process modeling into their regulatory submissions. Process models are described as a growing scientific area and are being us…
    raps · 2mo agoRegulatoryNeutral↗ source
  • MHRA revises guidance on periodic safety update reports for UK products
    The Medicines and Healthcare products Regulatory Agency (MHRA) has issued an update to its pharmacovigilance procedures guidance. The revision focuses on the preparation and submission of periodic…
    raps · 2mo agoRegulatoryNeutral↗ source
  • FDA considers new deputy commissioner roles as Trump prepares to announce additional MFN drug pricing agreements
    The Food and Drug Administration is evaluating the establishment of new deputy commissioner positions to support its expanding portfolio of responsibilities. The proposal reflects ongoing efforts…
    raps · 2mo agoRegulatoryNeutral↗ source
  • FDA approves Revolution Medicines' Rasonque for metastatic pancreatic cancer
    Revolution Medicines received FDA approval for its oral RAS inhibitor daraxonrasib, branded as Rasonque, to treat patients with metastatic pancreatic adenocarcinoma who have already received prior…
    Fierce Biotech · 2mo agoApprovalPositive↗ source
  • FDA approves Rasonque, first-in-class RAS inhibitor for metastatic pancreatic cancer
    The U.S. Food and Drug Administration has approved Rasonque (daraxonrasib), a RAS inhibitor, for the treatment of metastatic pancreatic adenocarcinoma. Rasonque is a tablet taken once daily that t…
    fda press · 2mo agoApprovalPositive↗ source
  • Hansoh says China’s biopharma is shifting from follower to frontrunner, now behind 30% of investigational drugs
    Hansoh Pharmaceutical used its first‑half earnings release to claim that China’s innovative biopharma sector is moving from a follower role to a frontrunner position. The company highlighted that…
    Fierce Biotech · 2mo agoEarningsPositive↗ source
  • Spyre Therapeutics cuts rheumatoid arthritis program after weak Phase 2 TL1A antibody results
    Spyre Therapeutics reported that its Phase 2 study of the anti‑TL1A antibody SPY072 in rheumatoid arthritis did not meet the efficacy expectations set earlier this year. The company said the data f…
    Fierce Biotech · 2mo agoNegative readoutNegative↗ source
  • SK Biopharma signs $795 million licensing deal with Biohaven for epilepsy therapy opakalim
    SK Biopharma has entered a licensing agreement with Biohaven Pharmaceuticals to acquire worldwide rights to the Kv7 ion channel activator opakalim (BHV-7000) for epilepsy. The deal provides an upf…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Flagship’s ProFound Therapeutics secures up to $35 M from Gates Foundation to discover preeclampsia drug targets
    Flagship Pioneering’s ProFound Therapeutics has entered a new partnership with the Gates Foundation that could provide up to $35 million for research. The agreement includes an initial $20 million…
    Fierce Biotech · 2mo agoDealPositive↗ source
  • Early Inclusion of China Boosts Global Biotech Clinical Development Efficiency
    Many global biotech firms still treat China as a later-stage commercial market, adding it only after key development decisions. This practice often forces costly bridging studies, extends timelines…
    Fierce Biotech · 2mo agoPositive↗ source
  • Akeso reports phase 3 overall survival win for ivonescimab in advanced biliary tract cancer
    Akeso announced that its bispecific antibody ivonescimab combined with chemotherapy improved overall survival in a China phase 3 trial for advanced biliary tract cancer, beating the standard regime…
    Fierce Biotech · 2mo agoPositive readoutPositive↗ source